Self-scoring method and apparatus for early self-screening of neurological disease

ABSTRACT

A self-administered and self-scoring test kit and method for early self-screening of neurological disease, by detection of diminished olfactory function. The test kit is comprised of a plurality of pages; attached to each page ( 28 ) via adhesive is a microencapsulated strip ( 36 ) that, when scratched, releases a different, distinct odor. The test kit has instructions that provide for self-administration ( 33 ) and self-scoring ( 46 ) of the test, and identification of a threshold score ( 48 ) as a self-screening method for possible neurological disease and need to consult a physician.

FIELD OF THE INVENTION

[0001] The present invention relates in general to a screening apparatusand method for evaluating a person's olfactory function and, moreparticularly, to a self-administered and self-scored apparatus andmethod for self-screening of human diseases and disorders.

BACKGROUND OF THE INVENTION

[0002] Alzheimer's Disease (AD) is a progressive, degenerative diseasethat affects the brain resulting in impaired thinking, uncharacteristicbehavior and memory loss. The disease manifests in the degeneration ofnerve cells responsible for memory and thought processes. AD has twophysiological hallmarks: (1) plagues of largely insoluble plaques ofbeta-amyloid that develop in areas of the brain responsible for memoryand cognitive functions and (2) neurofibrillary tangles, or abnormalcollections of twisted threads inside nerve cells. The ultimate cause ofthe disease remains unknown. Therefore, the diagnosis of AD can only becompletely confirmed by examination of brain tissue following death todetermine whether the levels of plaques and tangles in certain brainregions are characteristic of AD. Because there is no cure for AD, earlydiagnosis of AD is critical for patients in giving them the benefit ofdrug therapies that may alleviate more moderate, early symptoms of ADand enhance their quality of life. Early diagnosis allows for the mosteffective treatment, medical and social management, and personal andfamily planning.

[0003] In diagnosing AD, physicians employ a battery of diagnostictests, including a complete medical history, physical exam, blood andurine analysis, and memory and psychiatric assessment, such as theWechsler Memory Test and the Mini Mental State Examination. Assessmentof olfactory function is employed in diagnosing AD. Patients withvarious neurological disorders, including AD, Parkinson's Disease,Huntington's Disease, Down's Syndrome and schizophrenia, often suffer animpaired sense of smell. The patients exhibit signs of olfactorydysfunction even before the patients manifest other symptoms of AD.Differential olfactory performance recognized between healthy andaffected patients, along with lack of awareness of olfactory deficit,provide a mechanism for early screening and diagnosis of AD. Studiessuggest that assessment of olfactory function is more reliable thanstandard cognitive capacity tests, and that diminished sense of smell,along with other factors, such as memory loss and genetic factors,provides the best indicator of AD.

[0004] Two principal methods are used to clinically evaluate olfactoryfunction. In one method, vials of scented liquids, each with a distinctscent, are used to assess the examinee's sense of smell. A complete testkit requires several vials of liquid. The second method involves testcards with distinct odor strips affixed to each card. Odor is releasedwhen scented microcapsules within each strip are ruptured. Rupture isaccomplished either by scratching the surface of the strip or by removalof an adhesive securing the strip to the card. Examples of such testsinclude the 40-item University of Pennsylvania Smell IndentificationTest (UPSIT) and the 12-item Cross-Cultural Smell Identification Test(CC-SIT).

[0005] Both principal methods are designed for general evaluation ofolfactory function. The vial test is reused until the scent diminishes.The vial test requires a health care professional, such as a physicianor nurse practitioner, to administer and score the test and then readand interpret the results. The test card method may beself-administered, but a healthcare professional must still score thetest and then read and interpret the results. Both the vial test andtest card methods are designed for and dependent on the activeinvolvement of a healthcare professional to screen and interpret theresulting score for indications of neurological disease.

[0006] In the prior art tests, the required involvement of a healthcareprofessional has a number of disadvantages. The involvement of ahealthcare professional significantly increases the cost to anindividual desiring screening. Additionally, visits to a healthcareprofessional require a considerable time commitment. Furthermore,individuals may perceive mandatory professional involvement as aninvasion of privacy. Finally, anxiety and trepidation are oftenassociated with visiting a professional to assess neurological disease.Individually or in combination, these factors can easily dissuade apossible sufferer of neurological disease from early screening anddiagnosis. As a result, many individuals will deny themselves thebenefit of a useful diagnostic tool.

BRIEF DESCRIPTION OF THE DRAWINGS

[0007]FIG. 1 is the front view of the contents of the self-screeningolfactory test kit;

[0008]FIG. 2 is the front view of a self-contained, self-administered,and self-scoring olfactory test booklet;

[0009]FIG. 3A is the front view of the inside front cover of theolfactory test booklet and FIG. 3B is the front view of the outside backcover of the olfactory test booklet;

[0010]FIG. 4 is the front view of one odor page of a plurality ofsubstantially uniform odor pages contained in the olfactory testbooklet;

[0011]FIG. 5 is a three-dimensional view of one odor page of a pluralityof uniform odor pages contained in the test booklet;

[0012]FIGS. 6A, 6B, 6C, and 6D are the front views of the self-scoringand self-screening instructions and mechanism contained in the olfactorytest kit; and

[0013]FIGS. 7A, 7B, 7C, and 7D are flowcharts depicting theself-administered, self-scoring and self-screening olfactory testmethod.

DETAILED DESCRIPTION OF THE DRAWINGS

[0014] As shown in FIG. 1, a self-screening olfactory test kit includesa test booklet 12, a sharpened pencil 18, an information booklet 14, anda physician's information card 16. The components are packaged in asealed paper box 10 with an expiration date placed on the box.

[0015]FIG. 2 shows a self-contained, self-administered, disposable testbooklet 12 for detecting decreased olfactory function as an early signof neurological disease, in particular, Alzheimer's disease. Testbooklet 12 comprises a plurality of individual strips of paper eachmeasuring 32.0 cm in length by 8.0 cm in width. The strips are folded inhalf length-wise and are stapled twice in middle of the length, creatingpages in booklet form that are 16.0 cm in length by 8.0 cm in width.Test booklet 12 uses seven strips of paper, creating fourteen pages,each with a front side and a back side, when assembled, including twelveinside pages, a front cover and a back cover. The outside of the frontcover of test booklet 12 is illustrated in FIG. 2, including a label“Alzheimer's Home Screening Test” written across the center and the text“Important: Information booklet provided. Read the entire booklet priorto beginning this screening test. Follow the instructions carefully.”written in lower right corner 20. Inside front cover 22 is illustratedin FIG. 3A. Outside back cover 24 is illustrated in FIG. 3B. Inside backcover 38 is answer key 40 illustrated in FIG. 6A. Odor pages 28 aresubstantially uniform, each oriented to a different odor-containingsource, odor strip 36, and laid out as shown in FIG. 4. The first elevenodor pages 28 are blank on the back side. Back side of last odor page 44is illustrated in FIG. 6B.

[0016]FIG. 3A shows inside front cover 22 of test booklet 12. Bulletedpoints labeled “important” are written on inside front cover 22. Thebulleted points include: (1) smell loss is the among the first signs ofAlzheimer's disease; this screening test measures your ability to smell;(2) do not attempt this screening test if you currently have nasalcongestion or long-lasting smell loss due to other known causes; (3) donot scratch the odor strip until you are ready to sniff the odor; (4)poor performance on this screening test does not necessarily mean youhave Alzheimer's disease; (5) this screening test works only if thedirections are followed precisely as noted; (6) this screening test canonly be used one time and prior to the expiration date; discard afteruse; (7) decreased olfactory function (sense of smell) is not the onlyindicator of Alzheimer's disease; (8) decreased olfactory function(sense of smell) can be found in older individuals without Alzheimer'sdisease; (9) do not turn to the answer key or look at the answer keyuntil you have completed the test.

[0017]FIG. 3B shows outside back cover 24 of test booklet 12. Bulletedpoints labeled “test booklet storage and handling” are written onoutside back cover 24. The bulleted points include: (1) store thisscreening test kit in a dry place below 86° F. (30° C.); do notrefrigerate; (2) do not scratch microencapsulated odor strips untilready to use; (3) sniff microencapsulated odor strips immediately afterscratching; (4) do not contact microencapsulated odor strips with anyliquid; (5) do not re-use microencapsulated odor strips; discard testafter use; (6) this screening test can only be used one time and priorto the expiration date. Phrase 26 “single use only —discard after use”is written below the bullet points.

[0018]FIG. 4 shows one odor page 28 of a plurality of substantiallyuniform pages. Test booklet 12 is comprised of twelve substantiallyuniform pages. The back of odor page 28 is blank, except back side oflast odor page 44 which is shown in FIG. 6B. Each odor page 28 containsthe same instructions 30 on the left side of the front of odor page 28labeled “easy step-by-step instructions.” Instructions 30 compriseillustrated step-by-step directions for self-administration of the test.The first instruction is numbered as one and says “use pencil provided,scratch odor strip in a ZIG-ZAG.” Immediately under the instruction isan illustration of odor strip 36 with a zig-zag line crossinghorizontally from the left to the right, back to the left and then againto the right. The next instruction is numbered as two and says “placeodor strip directly under both nostrils and sniff.” To the right ofinstruction number two is an illustration of odor page 28 of testbooklet 12 with an arrow pointing from odor strip 36 to the right to anillustration of a front view of a human head, the arrow terminatingbelow the nostrils. The next instruction is numbered three and says“circle the best answer. You must circle one answer.” Immediately underthe instruction is the phrase “your choice” with a circle around it. Thenext instruction, numbered four, says “turn the page,” and has noillustration. The next eleven odor pages 28 contain identicalinstructions 30, in the same orientation.

[0019] The right side of the front of odor page 28 has an odor number32, labeled as “ODOR #,” written in the upper right corner. The firstodor page is labeled “Odor #1,” and each of the next eleven odor pages28 are labeled with an increasing sequential odor number 32, e.g., “Odor#2,” “Odor #3,” etc. Below odor number 32, the phrase “this odor smellsmost like:” is written. Immediately underneath that phrase, inparentheses, is written “circle one.”

[0020] Below the phrases, odor labels 34 are listed above theodor-containing source, odor strip 36. Odor labels 34 are displayed in aright-justified, vertical list with one odor label per horizontal line.Four possible odor labels 34 are listed as possible identities for eachodor strip 36 where one odor label is the correct identity for each odorstrip 36. Using four possible odor labels 34 for each odor strip 36decreases the expected score on the basis of random responding to three,or twenty-five percent. Therefore, this increases the probability that alow score, between four and eight, is due to olfactory dysfunction andnot a false-positive result due to malingering. The sets of odor labels34 as possible identities for each odor strip 36 are: (1) fruit,cinnamon, woody and coconut, where cinnamon is the correct identity; (2)turpentine, soap, dog and black pepper, where turpentine is the correctidentity; (3) motor oil, garlic, rose and lemon, where lemon is thecorrect identity; (4) apple, grass, smoke and grape, where smoke is thecorrect identity; (5) lemon, strawberry, chocolate and black pepper,where chocolate is the correct identity; (6) mint, rose, lime and fruitwhere rose is the correct identity; (7) watermelon, peanut, rose andpaint thinner, where paint thinner is the correct identity; (8) banana,garlic, cherry and motor oil, where banana is the correct identity; (9)smoke, whiskey, pineapple and onion, where pineapple is the correctidentity; (10) rose, lemon, apple and gasoline, where gasoline is thecorrect identity; (11) soap, black pepper, chocolate and peanut, wheresoap is the correct identity; (12) chocolate, banana, onion and fruit,where onion is the correct identity.

[0021] Odor labels 34 listed above are used because studies indicatethat particular scents corresponding to odor labels 34 are universallyfamiliar and recognizable by persons from a variety of cultures. Theterms used as odor labels 34 are also selected to maximize recognitionacross a diverse population. For example, the term “woody” is usedinstead of “pine” because “woody” is a culture-free response as opposedto “pine.” Using cross-culturally recognized odor labels 34 reducesexaminee confusion resulting from unfamiliarity with the scentcorresponding to each odor label. Therefore, false-positive test resultsdetecting examinee confusion due to cultural unfamiliarity with odorlabels 34, rather than actual olfactory dysfunction, are reduced.

[0022] Additionally, odor labels 34 are grouped in a particular mannerdescribed above because the scents corresponding to odor labels 34 oneach odor page 28 are different and distinct from one another. Providinggroupings of odor labels 34 with readily distinguishable scentsdecreases examinee confusion not due to actual olfactory dysfunction.Gross, rather than small, differences in scent between odor labels 34,decreases the likelihood of false-positive test results due to aconfusion between scents. Therefore, the particular selection andgrouping of odor labels 34 decreases the occurrence of false-positivetest results and increases the reliability of the olfactory test as anindicator of olfactory dysfunction.

[0023] A rectangle with rounded corners, the same dimensions as odorstrip 36, 4.0 cm. in length by 1.25 cm in width, illustrating where odorstrip 36 should be attached, is printed on the right bottom corner ofodor page 28. The printed rectangle allows for consistent uniformattachment of odor strip 36 to odor page 28 during assembly of testbooklet 12. Each odor page 28 has a different odor strip 36 attached inthe printed rectangle to odor page 28 via adhesive.

[0024]FIG. 5 is a three-dimensional view of odor page 28. Odor strip 36is an odor-containing source. Odor strip 36 contains a plurality ofrupturable microcapsules. A distinct scent is located within themicrocapsules which is emitted when the microcapsules rupture or burst,as a result of scratching the surface of odor strip 36 with pencil 18.Other objects can be used to scratch the surface of odor strip 36 so asto accomplish rupture. As the microcapsules are ruptured, a burst offragrance of the distinct scent contained within the microcapsules isgiven off. Pencil 18 is provided in the test kit for the examinee to useto scratch the surface of odor strip 36 and rupture the microcapsules.

[0025] Odor strip 36 is a rectangular strip of paper with roundedcorners measuring 4.0 cm in length by 1.25 cm in width. Each odor page28 contains one odor strip 36 each containing one of the followingodors: cinnamon, turpentine, lemon, smoke, chocolate, rose, paintthinner, banana, pineapple, gasoline, soap, and onion. A particular odorstrip 36 is chosen from the grouping of odor labels 34 to provide adiverse, cross-cultural olfactory test. Odor strips 36 comprise sixfood-related odor strips and six nonfood-related odor strips. Odorstrips 36 are also chosen based on commercial availability.

[0026] Each odor strip 36 has a unique distinguishing visual feature.Each odor strip 36 is a different color. The following color correspondsto each odor strip 36: (1) for cinnamon, brown; (2) for turpentine,light yellow; (3) for lemon, light green; (4) for smoke, peach; (5) forchocolate, light pink; (6) for rose, white; (7) for paint thinner, gray;(8) for banana, dark pink; (9) for pineapple, orange; (10) for gasoline,green; (11) for soap, dark yellow; and (12) for onion, blue. Differentcolored odor strips are used for post-assembly verification and qualityassurance. By color-coding the odor strips, each odor page 28 can bechecked to ensure that the correct odor strip 36 was attached to itsrespective corresponding odor number 32. Other colors can be used todistinguish odor strips 36. Additionally, other coding schemes usingdistinguishing visual features can be employed.

[0027]FIG. 6A is inside back cover 38 of test booklet 12 containinganswer key 40. Answer key cover 43 is paper, 16.0 cm in length by 7.0 cmin width attached 1.0 cm below the top of inside back cover 38 viaadhesive. The paper is dense to prevent the text of answer key 40 frombeing visible through answer key cover 43. The bottom of inside backcover 38 and bottom of answer key cover 43 are attached with a breakableseal. Answer key cover 43 hides answer key 40 from view until the sealis broken and answer key cover 43 is lifted to view answer key 40.

[0028] Inside back cover 38 is labeled “answer key.” Underneath thelabel is written “important: do not read this page until you havecompleted the test.” The label and text are located in the top 1.0 cm ofinside back cover 38, so as to be visible with answer key cover 43attached. The odor numbers and the corresponding answers, correctlyidentifying each odor-containing source, are listed vertically in twocolumns, six answers per column as follows: in the first, left column:Odor #1 =cinnamon; Odor #2=turpentine; Odor #3=lemon; Odor #4=smoke;Odor #5=chocolate; Odor #6=rose; in the second, right column: Odor#7=paint thinner; Odor #8=banana; Odor #9=pineapple; Odor #10=gasoline;Odor #11=soap; and Odor #12=onion. “Total number incorrect” is writtenon the bottom of FIG. 6A. Blank box 42, 3.0 cm in length by 1.0 cm inwidth, is an area to the right of the phrase for examinee to record thetotal number of odor-containing sources incorrectly identified.

[0029]FIG. 6B illustrates top half 46 of back side of last odor page 44.Top half 46 of FIG. 6B is labeled “scoring the test” and givesinstructions for self-scoring the olfactory test from answer key 40.Self-scoring reveals the number of odor-containing sources examineeincorrectly identified. The total number of incorrect identifications isused in self-screening a positive or negative result of the olfactorytest.

[0030] The step-by-step instructions for self-scoring are: (1) aftersniffing all 12 odor strips 36 and circling one answer per page, removeanswer key cover 43 and look at answer key 40, FIG. 6A, to the right ofthis page; (2) starting with Odor #1, compare the correct answer foundon answer key 40 with the one you circled; if the two do not match,place a line through Odor #1 on answer key 40; (3) a scoring example ifanswer key and the odor label choice do not match is given ininformation booklet 14; (4) if you chose correctly and the two match, goto Odor #2; continue until you have viewed and scored each odor forcorrectness (Odor #1 through Odor #12); (5) after comparing each of yourcircled answers to answer key 40, total the number of odors you haveplaced a line through (incorrect answers); and (6) write that number inblank box 42 provided on answer key 40.

[0031]FIG. 6B also illustrates bottom half 48 of back side of last odorpage 44. Bottom half 48 provides instructions for self-screening todetermine a positive or negative result of the olfactory test based onthe total number of incorrect answers self-scored from answer key 40.Bottom half 48 is labeled “reading the results.” Below the label are theself-screening instructions: “after carefully totaling the number ofincorrect answers and writing that number in the ‘total numberincorrect’ box, you can read your results. If you have 4 or moreincorrect items you should consult your physician. If you do not have 4or more incorrect items and are experiencing symptoms of Alzheimer'sdisease (see signs and symptoms of section found in the informationbooklet), contact your physician. Early Alert is not a diagnostic testnor a conclusive test for Alzheimer's disease. Early Alert has beendesigned to assist in early detection of possible Alzheimer's disease bytesting your sense of smell. Further testing is recommended. Poorperformance on this screening test does not necessarily mean you haveAlzheimer's disease. See information booklet.”

[0032]FIG. 6C is information booklet 14. Information booklet 14comprises one blue sheet of paper 28.0 cm in length by 16.75 cm inwidth. The paper is folded in half lengthwise to create a four pagebooklet that is 14.0 cm in length by 16.75 cm in width. On the firstpage, information booklet 14 is titled “Information Booklet” andsubtitled “Early Alert Home Screening Test for Alzheimer's Disease.”

[0033] The first page contains an initial instruction under the subtitleto “please read all of the instructions completely before performing thescreening test. The directions will help you correctly perform the testand read the results.” A telephone help line number and a websiteaddress are also listed. Following the initial instruction is textlabeled “information about the test.” The text states that “smell lossis among the first signs of Alzheimer's disease (AD). The Early AlertAlzheimer's Home Screening Test is a smell test that allows anindividual to determine if a loss of olfactory function (the ability tosmell) is present. Although not all older persons with smell loss haveAD, such loss, alone or in combination with memory problems and/orcertain genetic markers, is among the best predictors or indicators ofAD. Early Alert has been designed to assist in early detection ofpossible AD by determining if you have a degraded sense of smell.Failing the test does not necessarily mean you have AD. If you fail thescreening test you should consult your physician. If you do not fail thetest and are experiencing symptoms of AD (See Signs and Symptoms),consult your physician.”

[0034] Following the initial instruction are bulleted statements labeled“contents of the home screening test.” The text lists the contents ofthe test kit as described in FIG. 1. Next, bulleted statements labeled“test booklet storage and handling” follow. The bulleted statements arethe same as the bulleted points described on outside back cover 22.Additional bulleted statements labeled “test limitations” subsequentlyfollow. The statements are: (1) the Early Alert screening test worksonly if the directions are followed precisely as noted; (2) the EarlyAlert screening test kit can only be used one time and prior to theexpiration date; (3) decreased olfactory function (sense of smell) isnot the only indicator of potential AD; and (4) decreased olfactoryfunction (sense of smell) can be found in older individuals without AD.Finally, at the bottom of the first page is text labeled “test validityand reliability.” The text states that “this test is the most widelyemployed means of quantitatively assessing the sense of smell. Numerouspublished scientific and medical studies have employed this exact formatand a number have found smell loss to be among the first, if no thefirst signs of AD. In some cases these studies demonstrated that suchloss more or less predicts who, among at-risk individuals, will likelydevelop AD eventually.”

[0035] The second page, located on the reverse of the first page, istitled “directions” and subtitled “how to take the test.” The secondpage is divided into two sections. The first section is labeled“cautions,” and comprises bulleted statements. The statements are: (1)do not attempt the screening test if you currently have nasal congestionor long-lasting smell loss due to other known causes; (2) do not scratchthe odor strip until you are ready to sniff the odor; (3) poorperformance on the screening test does not necessarily mean you haveAlzheimer's disease; (4) read all of the contents of this informationbooklet before you begin the screening test; (5) do not turn to theanswer key or look at the answer key before completing the test.

[0036] The second section is labeled “directions” and containssequentially numbered instructions and illustrations. Instruction numberone is “open the screening test booklet to the first page, which istitled Odor #1.” The next two instructions are the same as the first twoinstructions 30 on odor page 28, with the same illustrations.

[0037] Instruction number four is “look at the choices provided on thepage located above the odor strip. If you are not sure or no smell ispresent, pick the one that seems closest. Circle the best answer. Youmust circle one answer.” Centered under instruction number four is thephrase “example of answer choice.” Centered below the phrase is avertical list, one choice per horizontal line, of four odor labels:fruit, cinnamon, coconut, and woody. Fruit is circled. Instructionnumber five is “turn the page of the test booklet to the second pagewhich contains Odor #2. Repeat Step 2 through Step 4 above.” Instructionnumber six is “continue this process until all 12 odor strips have beensniffed and an answer has been circled for each odor.”

[0038] The third page labeled “directions” comprises three sections. Thefirst section is labeled “how to score the test.” The text in the firstsection is the same as top half 46 of back side of last odor page 44.With the text is an illustration of how to self-score each answer. Theexample shows “Odor #1 Woody” with a line through, i.e. “Odor #1 Woody.”Additionally, an illustration of blank box 42, 1.75 cm in length by 0.4cm in width, is given to the right of the phrase “total numberincorrect.”

[0039] The second section is labeled “reading the results.” The text inthe second section is the same text found in bottom half 48 of back sideof last odor page 44. The third section is labeled “frequently askedquestions.” Seven questions, each question labeled on the left with a“Q,” are paired with an answer, labeled on the left with an “A.” Theseven questions and paired answers are: (1) Why do I want to take a homescreening test for Alzheimer's? Early diagnosis is very important.Increasing you awareness of possible Alzheimer's disease can help youreceive further testing which may lead to potential diagnosis. As aresult, you can increase your chance of benefiting from currenttreatments, improve your quality of life, resolve anxiety, and plan forthe future; (2) If I have trouble completing and scoring the test, whatshould I do? Call the telephone help line number or visit the websiteaddress given; (3) What if I have a stuffy nose from a cold and take thetest? Taking the test while having nasal congestion is not recommended.Wait until you are healthy and free of symptoms; (4) What should I do ifI do not smell anything at all on the odor strip? If you are not sure orno smell is present, pick the one that seems closest; (5) If I have 4 ormore odors incorrect do I have Alzheimer's disease? No! Failing thisscreening test does not mean you have Alzheimer's disease. If you had 4or more odors incorrect you should consult your physician; (6) If I haveless than 4 odors incorrect does that mean I do not have Alzheimer'sdisease? No, factors other than smell can be used in the Alzheimer'sdisease diagnosis process. If you have signs or symptoms of consult yourphysician. (see signs and symptoms); (7) Can I give my test to someoneelse? No! The test is a single use test.

[0040] The fourth page is untitled and contains three sections. Thefirst section is labeled “Alzheimer's Disease—more information.” Thefirst section provides general information on Alzheimer's Disease andlists websites with more information on Alzheimer's Disease. The secondsection is labeled “signs and symptoms.” The section begins with “thefollowing information is taken from a widely distributed list of warningsigns for Alzheimer's disease.” The statement is then followed eightitems arranged in a two column vertical unnumbered list, with four itemsin each column. The items in the first, left column are: (1) misplacingthings; (2) word finding problems; (3) poor or decreased judgment; and(4) recent memory loss. The items in the second, right column are: (1)difficulty performing familiar tasks; (2) disorientation to time andplace; (3) loss of interest; and (4) changes in mood or behavior. Thethird section is labeled “medical and scientific references.” The thirdsection lists journal articles on Alzheimer's Disease and olfactorydysfunction.

[0041]FIG. 6D is physician's information card 16 labeled “physician'sinformation.” Physician's information card 16 comprises one sheet ofpaper, 17.0 cm in length by 8.5 cm in width. Physician's informationcard 16 has text printed on both the front side of the card and the backside of the card. Immediately below the title on the front side of thephysician's information card are the statements: “we strongly recommendthat you bring this card with you when conferring with your physician.We also suggest that you bring the screening test and informationbooklet.” Physician information card 16 is then formatted as a letter tothe physician, beginning, “dear physician.” The text of the letterexplains the olfactory test methodology and indications of a positiveresult.

[0042]FIG. 7A is a flowchart of the preparation for self-administrationthe olfactory test. An examinee opens in step 60 the sealed paper box 10and removes in step 60 the contents: test booklet 12, informationbooklet 14, physician information card 16, and pencil 18. In step 62,examinee reads information booklet 14.

[0043] In step 64, if examinee has long lasting smell loss due to otherknown causes, examinee is instructed in step 76 not to take theolfactory test. If not, but in step 66 examinee currently has nasalcongestion, examinee is instructed in step 78 not to take the olfactorytest and, in step 86, to store the test until nasal congestion clears.In steps 80 through 84, examinee stores the test in a dry place at atemperature below 30° C. (86° F.), but does not refrigerate the test. Ifexaminee fails to comply with the storage instructions, then step 76instructs examinee not to take the olfactory test and to discard thetest.

[0044] If examinee has no nasal congestion in step 66 or if nasalcongestion has cleared in step 86, but the expiration date in step 68has passed, examinee is instructed in step 76 not to take the olfactorytest and to discard the test. If the expiration date in step 68 has notpassed, but in step 70 if any odor strip 36 has come into contact withany liquid, or in step 72 if any odor strip 36 has been scratched, step76 instructs examinee not to take the olfactory test and to discard thetest. If not, then in step 74, examinee may begin the olfactory test.

[0045]FIG. 7B is a flowchart of the self-administration method of theolfactory test. In step 88, examinee breaks the seal of test booklet 12and in step 90 opens test booklet 12 to inside front cover 22. In step92, examinee reads the points labeled “important” on inside front cover22. If examinee has looked at answer key 40 in step 94, then in step 96,examinee is instructed not to take the olfactory test. In step 94, ifexaminee has not looked at answer key 40, then in step 98, examineelooks at first odor page 28.

[0046] In step 100, examinee uses the sharp end of pencil 18 to scratchodor strip 36 several times in a zig-zag fashion, releasing the odorfrom the odor-containing area. In step 102, examinee places odor strip36 directly under both nostrils and in step 104, sniffs odor strip 36.In step 106, examinee looks at odor labels 34 and in step 108, usespencil 18 to circle the odor label that odor strip 36 smells most like.In step 110, if odor page 28 is not odor #12, then in step 112, examineeturns to the next odor page 28 and repeats steps 100 through 110. Whenin step 110 the odor number is twelve, then examinee begins to score thetest in step 114.

[0047]FIG. 7C is a flowchart of the olfactory test's self-scoring methodto determine a number of incorrect answers that indicate a positiveresult. In step 114, after examinee circles an odor label for Odor #12,examinee turns in step 116 to back side of last page 44, and in step 118reads the “scoring the test” section on top half 46. In step 120,examinee looks at answer key 40 on inside back cover 38. In step 122,examinee looks at the answer for odor #1. In step 124, examinee thenlooks at the circled odor label for odor #1. In step 126, if the circledlabel for odor #1 matches the answer for odor #1 in answer key 40,examinee looks at the next odor number and repeats steps 124 through132. If in step 126, the answer for odor #1 does not match the circledodor label for odor #1, then examinee, in step 128, uses pencil 18 todraw a line through the answer in answer key 40, and then repeats steps124 through 132.

[0048] When in step 132, the odor number is twelve, examinee counts instep 134 the answers in answer key 40 with a line through (the incorrectanswers). In step 136, examinee records the total number of incorrectanswers in blank box 42 provided next to the phrase “total incorrectnumber.” In step 138, examinee then self-screens the score.

[0049]FIG. 7D is a flowchart of the olfactory test's self-screeningmethod to determine a positive or negative result from the total numberof incorrect answers self-scored from answer key 40. In step 140,examinee reads bottom half 48 of back side of last odor page 44,“reading the results.” If examinee's total incorrect number is four ormore, examinee is instructed to consult a physician in step 150. If theexaminee needs to consult a physician in step 150, then examinee isfurther instructed in step 152 to take physician's information card 16to the physician.

[0050] Recording a score of four or more incorrect answers on a twelveodor strip test reveals a statistically significant probability ofolfactory dysfunction that is an early detectable symptom ofneurological disease, in particular, of Alzheimer's Disease (AD).Studies have shown that incorrectly identifying at least one-third of atotal number of odor strips indicates olfactory dysfunction attributableto AD. For example, studies report that one hundred percent of patientsdiagnosed with AD incorrectly identified one-third or more of a totalnumber of odor strips (in this case, one or more odor strips in a threeodor strip test); whereas only twenty percent of patients not currentlydiagnosed with AD incorrectly identified one out of three odor strips.Additionally, in the same studies, none of the non-AD patientsincorrectly identified more than one-third of the odor strips; whereasbetween seventy-five to ninety-five percent of the AD patientsincorrectly identified more than one-third of the odor strips.

[0051] In a twelve-item olfactory test, another study reports thatninety-nine percent of individuals age 45 to age 49 recording a score offour of more incorrect answers suffer from olfactory dysfunction.Additionally, at least ninety percent of women and seventy-two percentof men age 65 to age 69 correctly identifying eight or less of thetwelve odor strips (scoring four incorrect answers) suffer fromolfactory dysfunction.

[0052] In step 142, if examinee's total incorrect number is less thanfour, then examinee is instructed in step 144 to read the section ininformation booklet 14 labeled “signs and symptoms.” In step 146, ifexaminee is experiencing any of the listed signs or symptoms ofAlzheimer's Disease, examinee is instructed in step 150 to consult aphysician. If the examinee needs to consult a physician in step 150,then examinee is further instructed in step 152 to take physician'sinformation card 16 to the physician. If examinee's total numberincorrect is less than four in step 142 and examinee is not experiencingany listed signs or symptoms of Alzheimer's Disease in step 146,examinee in step 148 needs to take no further action.

[0053] The self-screening olfactory test kit eliminates the need forhealthcare professional involvement for initial screening ofneurological disease. The olfactory test kit requires only a small timecommitment since an individual can self-administer and self-score theolfactory test in about five minutes. Additionally, the cost of theolfactory test kit for individual desiring initial screening ofneurological disease is minimal compared with an office visit to ahealthcare professional.

[0054] The olfactory test kit provides individuals with a simpleself-screening method to determine a positive result of the olfactorytest upon incorrectly identifying one-third or more of the total numberof odor-containing areas. A positive result of the olfactory test is anindication of olfactory dysfunction which is not a diagnosis ofneurological disease rather an indication that an individual should takefurther action regarding possible neurological disease, such asconsulting a physician. Individuals not only self-administer theolfactory test in a private, in-home setting, but also self-score theolfactory test to determine themselves if the results indicate thatfurther action is required. The olfactory test kit is a quick,inexpensive, private, self-screening, diagnostic tool that does notincur anxiety associated with healthcare professional involvement. As aresult, the olfactory test kit will avail more individuals of thebenefits of early screening of possible neurological disease.

[0055] Although the present invention has been described with respect topreferred embodiments, any person skilled in the art will recognize thatchanges may be that changes be made in form and detail, and equivalentsmay be substituted for elements of the invention without departing fromthe spirit and scope of the invention. Many modifications may be made toadapt to a particular situation or material to the teaching of theinvention without departing from the essential scope of the invention.Therefore, it is intended that the invention not be limited to theparticular embodiments disclosed for carrying out this invention, butthat the invention will include all embodiments falling within the scopeof the appended claims.

What is claimed is:
 1. An olfactory test for self-screening of aneurological disease, comprising: a booklet including a plurality ofpages; an odor-containing source on one page of the plurality of pages;a plurality of labels providing choices of possible identity of theodor-containing source; an answer key on one page of the plurality ofpages correctly identifying the odor-containing source; and aninstruction on one page of the plurality of pages for self-scoring theolfactory test from the answer key to determine a number of incorrectanswers that indicate a positive result of the olfactory test.
 2. Theolfactory test of claim 1, further including a first instruction to takefurther action regarding the neurological disease upon self-scoring thepositive result of the olfactory test.
 3. The olfactory test of claim 1,wherein the instruction includes: a first instruction to compare aselected label from the plurality of labels to the answer key; a secondinstruction to indicate an incorrect answer; and a third instruction toascertain the number of incorrect answers.
 4. The olfactory test ofclaim 1, further including a first instruction to take further actionupon a negative result of the olfactory test yet experiencing symptomsof the neurological disease.
 5. The olfactory test of claim 1, whereinthe answer key includes a correct answer for each odor-containing sourcesuch that incorrect answers can be indicated.
 6. The olfactory test ofclaim 1, further including an area to record the number of incorrectanswers.
 7. The olfactory test of claim 1, further including a coverover the answer key.
 8. The olfactory test of claim 1, wherein theplurality of labels selected for the odor-containing source aredistinctly different from one another.
 9. The olfactory test of claim 1,wherein the odor-containing source has a unique distinguishing visualfeature.
 10. The olfactory test of claim 1, wherein the neurologicaldisease is Alzheimer's disease.
 11. An olfactory test booklet,comprising: a first page including an instruction for use of anolfactory test; a plurality of second pages each including anodor-containing source; a plurality of labels providing choices ofpossible identity for each odor-containing source; a third pageincluding an answer key correctly identifying each odor-containingsource; and a fourth page including an instruction for self-scoring theolfactory test from the answer key to determine a number of incorrectanswers that indicate a positive result of the olfactory test.
 12. Theolfactory test booklet of claim 11, further including: a first pageincluding, (a) a first instruction to compare a selected label from theplurality of labels to the answer key; (b) a second instruction toindicate an incorrect answer; and (c) a third instruction to ascertainthe number of incorrect answers.
 13. The olfactory test booklet of claim11, wherein the answer key includes a correct answer for eachodor-containing source such that incorrect answers can be indicated; 14.The olfactory test booklet of claim 11, further including a first pagewith an area to record the number of incorrect answers.
 15. Theolfactory test booklet of claim 11, further including a cover over theanswer key.
 16. The olfactory test booklet of claim 11, wherein theplurality of labels selected for the odor-containing source aredistinctly different from one another.
 17. The olfactory test booklet ofclaim 11, wherein four labels are selected for each odor-containingsource.
 18. The olfactory test booklet of claim 11, wherein theodor-containing source has a unique distinguishing visual feature.
 19. Amethod of self-screening of a neurological disease, comprising:providing an odor-containing source capable of releasing an odor;providing a plurality of labels as choices of possible identity of theodor-containing source; providing an answer key which correctlyidentifies the odor-containing source to compare against a selectedlabel from the plurality of labels; and providing an instruction forself-scoring using the answer key to determine a number of incorrectlyselected labels that indicate a positive result.
 20. The method ofself-screening in claim 19, further including providing a firstinstruction to take further action regarding the neurological diseaseupon the positive result.
 21. The method of self-screening in claim 19,further including providing a first instruction to take further actionupon a negative result yet experiencing symptoms of the neurologicaldisease.
 22. The method of self-screening in claim 19, further includingproviding a cover over the answer key.
 23. The method of self-screeningin claim 19, further including selecting a plurality of labels for theodor-containing source that are distinctly different from one another.24. A method of manufacturing an olfactory test booklet, comprising:assembling the olfactory test booklet including a plurality of pages;printing a first page including an instruction for use of an olfactorytest; printing a second page and applying an odor-containing source tothe second page; printing a plurality of labels providing choices ofpossible identity for each odor-containing source; printing a third pageincluding an answer key correctly identifying each odor-containingsource; and printing a fourth page including an instruction forself-scoring the olfactory test from the answer key to determine anumber of incorrect answers that indicate a positive result of theolfactory test.
 25. The method of manufacturing in claim 24, furtherincluding printing a plurality of second pages and applying oneodor-containing source to each page of the plurality of second pages.26. The method of manufacturing in claim 24, further includingassembling a cover over the answer key.
 27. The method of manufacturingin claim 24, further including printing a first page including an areato record the number of incorrect answers.
 28. An olfactory test kit forself-screening of a neurological disease, comprising: an odor-containingsource capable of releasing an odor; an area for recording possibleidentity of the odor; an answer key correctly identifying the odor; andan instruction for self-scoring the olfactory test from the answer keyto determine a number of incorrect answers that indicate a positiveresult.
 29. The olfactory test kit in claim 28, wherein the area forrecording the possible identity of the odor includes a plurality oflabels providing choices of the possible identity of the odor.
 30. Theolfactory test kit in claim 28, wherein the olfactory test is a booklet.31. The olfactory test kit in claim 28, further including a first sheetwith an instruction for use of the olfactory test.
 32. The olfactorytest kit in claim 28, further including a first sheet with aninstruction about the olfactory test for a healthcare professional. 33.The olfactory test kit in claim 28, further including an instrument forreleasing the odor from the odor-containing source.
 34. The olfactorytest kit in claim 28, further including a cover over the answer key. 35.The olfactory test kit in claim 28, further including an area to recordthe number of incorrect answers.
 36. The olfactory test kit in claim 28,further including an instrument for recording the possible identity ofthe odor-containing source.
 37. The olfactory test kit in claim 28,further including an instrument for self-scoring the olfactory test.